The Impact of Targeted Temperature Management Duration on Thrombin Function in Cardiac Arrest Patients (ITTC)

Tang Ziren

Status: Active, not recruiting

Conditions: Thrombin Function; Treatment Duration; Cardiac Arrest; Targeted Temperature Management

Treatments: Procedure: Target Temperature Management Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06543849

2023-1-26-5

Details and patient eligibility

About

This study will be a single-center, prospective, randomized controlled trial with an estimated sample size of 64 patients. Eligible patients will be randomly assigned in a 1:1 ratio to receive TTM for either 24 hours or 72 hours. The primary outcome measure will be the changes in thrombin function indices at various time points during TTM treatment in both groups. The secondary endpoints of the study include additional coagulation function indicators, the incidence of bleeding-related events between the two groups, the amount of blood products used, the incidence of thrombotic events, and the CPC scores at 28 days and 6 months for both groups.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age between 18 and 80 years;
2. Glasgow Coma Scale score of less than 8 upon admission;
3. patients resuscitated after out-of-hospital cardiac arrest; and (4) patient or their legal representative has signed the informed consent form.

Exclusion criteria

1. cardiac arrest caused by irreversible factors such as trauma or poisoning;
2. cardiac arrest due to terminal conditions like advanced cancer;
3. uncorrected persistent cardiogenic shock, defined as a systolic blood pressure below 90 mmHg despite treatment with fluid resuscitation, vasopressors, and inotropic agents;
4. pre-existing cerebrovascular disease or CT-confirmed intracerebral hemorrhage upon admission;
5. pre-arrest Cerebral Performance Category (CPC) score between 3 and 5;
6. bradycardia or sick sinus syndrome following the return of spontaneous circulation;
7. pre-existing coagulation disorders or severe bleeding tendencies;
8. pregnant or breastfeeding women, or women of childbearing age with elevated serum hCG levels;
9. presence of treatment limitations (such as refusal by the patient or legal representative to undergo advanced life support, including mechanical ventilation, chest compressions, or targeted temperature management);
10. determination by the principal investigator that the patient is unsuitable for the trial.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

24-hour treatment

Sham Comparator group

Treatment:

Procedure: Target Temperature Management Treatment

72-hour treatment

Active Comparator group

Treatment:

Procedure: Target Temperature Management Treatment